A Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

Official Title ICMJE

A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Brief Summary

This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy.

MK-3102 (25 mg) will be administered in a blinded manner as one capsule once a week (q.w.)

Drug: MK-3102 Placebo

Placebo matching MK-3102 (25 mg)

Drug: Glimepiride

Glimepiride (1 mg and/or 2 mg tablets).

During the double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.

Other Names:

AMARYL®

GLIMY

Drug: Glimepiride Placebo

Placebos matching glimepiride 1 mg and/or 2 mg

Drug: Metformin

Open-label

Drug: Insulin Glargine

Insulin glargine can be used for rescue therapy, if glycemic control is not maintained.

Study Arm (s)

Experimental: MK-3102

Interventions:

Drug: MK-3102

Drug: Glimepiride Placebo

Drug: Metformin

Drug: Insulin Glargine

Active Comparator: Glimepiride

Interventions:

Drug: MK-3102 Placebo

Drug: Glimepiride

Drug: Metformin

Drug: Insulin Glargine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

751

Completion Date

January 2015

Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Diagnosed with Type 2 diabetes mellitus

On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control

Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

Exclusion Criteria:

History of type 1 diabetes mellitus or a history of ketoacidosis

Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with MK-3102 at any time prior to signing informed consent

On a weight loss program and is not in the maintenance phase or has

started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation